[Congressional Record Volume 140, Number 84 (Tuesday, June 28, 1994)]
[Senate]
[Page S]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]


[Congressional Record: June 28, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]

 
                             CLOTURE MOTION

  The PRESIDING OFFICER. The hour of 6 p.m. having arrived, under the 
previous order, the clerk will report the motion to invoke cloture.
  The assistant legislative clerk read as follows:

                             Cloture Motion

       We, the undersigned Senators, in accordance with the 
     provisions of rule XXII of the Standing Rules of the Senate, 
     hereby move to bring to a close the debate on Calendar No. 
     409, S. 687, a bill to regulate interstate commerce by 
     providing for a uniform product liability law:
         Jay Rockefeller, J. Lieberman, John Glenn, Claiborne 
           Pell, Bob Kerrey, J.J. Exon, Harlan Mathews, Slade 
           Gorton, Orrin G. Hatch, Strom Thurmond, Daniel Coats, 
           Judd Gregg, Dirk Kempthorne, Pete V. Domenici, Larry 
           Pressler, Kay Bailey Hutchison, Frank H. Murkowski.


                                  vote

  The PRESIDING OFFICER. By unanimous consent, the quorum call has been 
waived.
  The question is, Is it the sense of the Senate that the debate on S. 
687, the product liability fairness bill, shall be brought to a close?
  The yeas and nays are automatic under the rule, and the clerk will 
call the roll.
  The legislative clerk called the roll.
  Mr. METZENBAUM. Mr. President, on this vote I have a pair with the 
distinguished Senator from Arizona [Mr. DeConcini]. If he were present 
and voting, he would vote ``yea.'' If I were at liberty to vote, I 
would vote ``nay.'' Therefore, I withhold my vote.
  Mr. FORD. I announce that on this vote, the Senator from Arizona [Mr. 
DeConcini] is paired with the Senator from Ohio [Mr. Metzenbaum].
  If present and voting, the Senator from Arizona would vote ``aye'' 
and the Senator from Ohio would vote ``nay.''
  The PRESIDING OFFICER (Mr. Mathews). Are there any other Senators in 
the Chamber who desire to vote?
  The yeas and nays resulted--yeas 54, nays 44, as follows:

                      [Rollcall Vote No. 169 Leg.]

                                YEAS--54

     Bennett
     Bond
     Boren
     Brown
     Burns
     Byrd
     Chafee
     Coats
     Coverdell
     Craig
     Danforth
     Daschle
     Dodd
     Dole
     Domenici
     Durenberger
     Exon
     Faircloth
     Glenn
     Gorton
     Gramm
     Grassley
     Gregg
     Hatch
     Hatfield
     Helms
     Hutchison
     Jeffords
     Kassebaum
     Kempthorne
     Kohl
     Lieberman
     Lott
     Lugar
     Mack
     Mathews
     McCain
     McConnell
     Mikulski
     Murkowski
     Nickles
     Nunn
     Packwood
     Pell
     Pressler
     Pryor
     Riegle
     Robb
     Rockefeller
     Sasser
     Smith
     Stevens
     Wallop
     Warner

                                NAYS--44

     Akaka
     Baucus
     Biden
     Bingaman
     Boxer
     Bradley
     Breaux
     Bryan
     Bumpers
     Campbell
     Cochran
     Cohen
     Conrad
     D'Amato
     Dorgan
     Feingold
     Feinstein
     Ford
     Graham
     Harkin
     Heflin
     Hollings
     Inouye
     Johnston
     Kennedy
     Kerrey
     Kerry
     Lautenberg
     Leahy
     Levin
     Mitchell
     Moseley-Braun
     Moynihan
     Murray
     Reid
     Roth
     Sarbanes
     Shelby
     Simon
     Simpson
     Specter
     Thurmond
     Wellstone
     Wofford

       PRESENT AND GIVING A LIVE PAIR, AS PREVIOUSLY RECORDED--1

       
     Metzenbaum
       

                             NOT VOTING--1

       
     DeConcini
       
  The PRESIDING OFFICER. On this vote, the yeas are 54, the nays are 
44. Three-fifths of the Senators duly chosen and sworn not having votes 
in the affirmative the motion is rejected.
  The majority leader.
  Mr. MITCHELL. Mr. President, I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Mr. WOFFORD addressed the Chair.
  Mr. FORD. Mr. President, I will have to object to taking off the 
quorum call.
  The PRESIDING OFFICER. Objection is noted. The clerk will call the 
roll.
  Mr. FORD. I apologize.
  The legislative clerk continued with the call of the roll.
  Mr. MITCHELL. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                          amenndment no. 1930

  Mr. CHAFEE. Mr. President, I am intrigued by the amendment offered by 
the Senator from Wisconsin, but I will not be supporting his amendment 
today.
  I am hesitant for Congress to move forward with this amendment for 
two reasons. As my colleagues know, there already is in place a process 
by which the rules may be changed; and this process involves a 
recommendation by the U.S. Judicial Conference, and approval by the 
U.S. Supreme Court. This process is in place because we have decided 
that we should give due deference to the Conference to determine how 
best the courts may serve the American public.
  Now, Congress may certainly go ahead and propose changes absent a 
recommendation from the Conference. But I would note also that in this 
matter, even the administration has asked us to hold off until they 
have determined what they view as the best course of action.
  Thus, in the absence of a clear recommendation from either the 
Judicial Conference or the administration, both of which could and 
should provide some guidance on this matter, I am not comfortable 
moving forward with this amendment.
  I do feel, however, that this is an issue that needs to be pursued, 
and I hope the Judicial Conference and the administration will move 
expeditiously to come up with appropriate recommendations. This is not 
a matter that should be delayed.


             disastrous effects of product liability reform

  Mr. GRAHAM. Mr. President, today, I met Ms. Marlo Mahne, a Floridian 
whose story speaks volumes about the reasons the product liability bill 
we are considering today should be defeated.
  Ms. Mahne was horribly burned in a 1985 automobile accident in Fort 
Pierce, FL. She was able to reach a settlement with the manufacturer of 
the car in which she was a passenger. If S. 687 had been law in 1985, 
the settlement she reached would never have been possible, Ms. Mahne 
says. Further, if it is enacted now, it will prevent people who suffer 
similar tragedies in the future from recovering the damages to which 
they are entitled.
  Mr. President, I have a statement here by Marlo Mahne which describes 
her experience in her own words. I ask that it be included in the 
Record and offer it as another of the many reasons this unwise 
legislation should be rejected by the Senate.
  There being no objection, the letter was ordered to be printed in the 
Record, as follows:

                Statement of Marlo Mahne, June 27, 1994

       My name is Marlo Mahne. In 1985, when I was fifteen years 
     old, the 1967 Ford Mustang in which I was a passenger was 
     struck from behind. This is the same car that President 
     Clinton owns and drives. Because the fuel tank in the Mustang 
     was defective, it ruptured and the car burst into flames.
       I had 3rd and 4th degree burns over 70 percent of my body. 
     Nearly all of my scalp was burned off. My ears and fingers 
     were burned off. My lips and nose have been reconstructed. I 
     am blind in one eye.
       My initial stay in the hospital lasted 4 months, and I was 
     in and out over the next 18 months. Altogether I have had 118 
     major plastic surgeries and procedures, and I could have 20 
     or 30 more.
       I sued the Ford Motor Company, and in 1991 my case was 
     settled out of court. Before then Ford did everything to 
     avoid the blame for what happened to me. Fortunately at the 
     time, Ford didn't have S. 687 to hide behind.
       Ford said the underinsured driver of the Mustang and the 
     uninsured driver of the bullet car were at fault and should 
     bear equal responsibility. But those people didn't design a 
     defective fuel tank, ignore the defect, and put it on the 
     road.
       You have in your packet an excerpt from the deposition of 
     Harold MacDonald, who was the vice president of Ford's 
     engineering research. Mr. MacDonald acknowledged that the 
     Mustang's fuel tank repeatedly ruptured in Ford's own tests, 
     but Ford did not act to correct the defect.
       If it weren't for Ford, I might have walked away from the 
     crash. Instead, I will be a dependent person probably for the 
     rest of my life. The only thing that prevents me from being a 
     burden to taxpayers is the settlement I finally secured from 
     Ford. Now, because of S. 687, that is at risk for future 
     victims of defective products.
       Although I am prohibited by a secrecy order from discussing 
     the settlement of my case and some of the details, I can tell 
     you that if Senate Bill 687 had been the law, it would have 
     shielded Ford from full responsibility for what the company 
     did to me.
       Economic damages for me were modest at the time of the 
     crash because I was too young to work and my medical bills 
     were paid by the Shriners. The non-economic damages I sought 
     would have been greatly reduced if S. 687 had been the law 
     because there were three possible defendants: two drivers and 
     Ford.
       Under S. 687, even though I would not have been burned if 
     the gas tank wasn't defective, Ford could claim it was 
     responsible for only one-third of my non-economic damages, 
     such as pain and suffering, which for me has been everything. 
     I don't think this is fair.
       I am not an attorney, but as you might imagine, I've 
     learned a lot about the law since I was burned by Ford. I 
     thank God that I was able to have my case heard and that the 
     law today isn't designed to save money for manufacturers but 
     rather to pay for the harm caused the consumer. S. 687 would 
     take all that away from someone like me.

  Mr. DURENBERGER. Mr. President, I rise today in strong support of the 
Product Liability Fairness Act. I would like to thank my colleagues 
Senators Rockefeller, Lieberman, Dodd, Gorton, and Danforth for their 
leadership in bringing this legislation to the floor. I am proud to 
join them in cosponsoring this important legislation.
  I believe strongly that S. 687 will bring both cost-savings and 
consumer safety to our current product liability system--fairly and 
effectively.
  S. 687 will reduce costs to consumers, stimulate product innovation, 
promote U.S. competitiveness and, at the same time, ensure that 
consumers have access to more safe and effective products.


           A National Problem In Need Of A National Solution

  Our Nation's product liability system is broken. It is badly broken, 
and it is a problem which calls for us to respond with a national 
solution. The current system does not fairly protect the injured, 
stifles the development of innovative products, and harms U.S. 
competitiveness.
  About 70 percent of manufactured products are sold outside the State 
in which they are made. The current patchwork system of State-by-State 
product liability legislation poses a burden to interstate commerce and 
encourages forum shopping.
  In fact, the National Governors' Association [NGA] has continually 
urged Congress to enact uniform product liability law. In a letter last 
year to President Clinton, the NGA wrote: ``Clearly, a national product 
liability code would greatly enhance the effectiveness of interstate 
commerce.''


 s. 687 will make product liability laws more fair to injured consumers

  Several recent studies have found that people who are severely 
injured by products are compensated for only a small fraction of their 
economic losses. Those studies found that claimants' recoveries for 
losses exceeding $1 million are less than 39 percent. In contrast, 
those with minor injuries recover a windfall of nearly five times their 
losses.
  A 1989 GAO study found that product cases take about 3 years to 
resolve, and even longer if there is an appeal. Because larger claims 
generally take longer to resolve than small claims, severely injured 
victims must wait years to receive compensation. These delays force 
those who are most severely injured to settle for inadequate amounts.
  Moreover, the cost of bringing a product liability lawsuit is 
outrageously high. A 1986 study by the Rand Institute for Civil Justice 
found that the annual transaction costs of the tort system exceed the 
compensation awarded to injured persons. A 1993 survey by the 
Association of Manufacturing Technology found that the lion's share of 
the costs associated with defending a product liability lawsuit go to 
attorneys' fees, subrogation, and court costs. Less than one-quarter of 
the total transaction costs associated with a product liability defense 
actually go to the injured party. This is clearly unacceptable.


the product liability system imposes excessive costs which are harmful 
                        to u.s. competitiveness

  Excessive product liability costs have resulted in significant market 
share loss for some U.S. companies. The U.S. machine tool industry, for 
example, has lost more than 20 percent of its domestic market share to 
foreign competitors whose liability costs are lower and far more 
predictable.
  Jobs have been lost in the United States as companies shift 
production abroad to take advantage of less stringent product liability 
laws. Innovative products made and marketed abroad are lost to U.S. 
consumers.
  The fear of product liability has also diminished investment in basic 
scientific research. Malcolm Skolnick, a lawyer and professor of 
biophysics at the University of Texas testified before the Commerce 
Committee that:

       Scientific inquiry is stifled. Ideas in areas where 
     litigation has occurred will not receive support for 
     exploration and development. Producers fearful of possible 
     suits will discourage additional investigation which can be 
     used against them in future claims.


the product liability system discourages innovation and advancements in 
                            medical products

  Perhaps the most critical reason I became involved in this issue is 
that the excessive costs of the current product liability system harm 
consumers and patients by discouraging innovation and development of 
lifesaving and cost-saving medical products.
  Jim Vincent, chairman and CEO of Biogen, told the Senate Commerce 
Committee that he has decided not to pursue research into the 
development of an AIDS vaccine because of the current product liability 
system. One company that is attempting to develop an AIDS vaccine told 
the Commerce Committee that it was forced to delay important clinical 
trials because of liability concerns.
  The research supports this anecdotal evidence. The Office of 
Technology Assessment found that the fear of potential liability is a 
serious barrier to research, testing, and marketing of vaccines. OTA 
recommends action by the Federal Government.
  Excessive product liability costs have also forced manufacturers to 
withdraw even successful products from the market. For example, in 
1983, Merrell Dow withdrew Benediction, an anti-nausea drug for 
pregnant women, because the cost of litigation arising out of use of 
the drug far exceeded revenue. The FDA and the health care 
professionals believe the product is safe; yet there is no comparable 
drug on the market. This, too, is unacceptable. Americans want new and 
better products that will improve their lives. They do not want to 
travel to other countries to illegally obtain drugs not approved in the 
United States, yet that happens on a regular basis. Part of this 
problem relates to the slow FDA approval process, but product liability 
weights heavily here as well.


       biomaterials shortage threatens access to medical products

  Mr. President, I also want to speak briefly on behalf of the 
amendment that will be offered by my colleague from Connecticut and is 
based on a bill we introduced last week: the Biomaterials Access 
Assurance Act of 1994.
  This amendment, in my opinion, represents a significant step forward 
in reducing the costs of medical devices. It would reform our product 
liability laws to assure raw material suppliers that they will not be 
held liable unless there is real evidence that they were responsible 
for the product defect.
  Our current product liability system makes it much too easy to bring 
lawsuits against raw materials suppliers, and too costly for those 
suppliers to defend themselves even when they ultimately win. Unless we 
include protections for raw material suppliers in this legislation, 
those who make many of the lifesaving medical devices that we take for 
granted today may no longer be able to purchase the raw materials and 
components necessary to produce their products.
  Notwithstanding the fact that raw materials and component parts 
suppliers do not design, produce or test medical implants and devices, 
they have been sued in cases alleging inadequate design and testing of 
permanently implanted medical devices, testing of those devices, and 
warnings related to those devices. And even though these suppliers have 
almost never been held liable in these lawsuits, the cost of litigation 
far exceeds the total potential sales of raw materials and component 
parts to the medical device industry. As a result, many suppliers have 
simply stopped supplying raw materials and component parts to medical 
device manufacturers.
  We in Congress must not allow the 7.4 million people who literally 
owe their lives and the quality of their lives to medical devices--and 
the countless others who will depend on medical devices in the years to 
come--to become casualties of our outmoded product liability system.
  I urge the support of my colleagues for the Lieberman-Durenberger 
amendment.


                             fda provision

  Mr. President, concerns have been raised by some of my colleagues in 
recent days about section 203(b) of this bill, which provides that 
manufacturers of drugs or medical devices that have been approved by 
the Food and Drug Administration [FDA] shall not generally be subject 
to punitive damages in product liability litigation.
  In my view, Mr. President, it is unfortunate that this provision has 
drawn such negative responses. I believe that section 203(b) is the 
most important provision of the Product Liability Fairness Act. And I 
strongly urge my colleagues: If we are ever going to be able to get a 
handle on runaway health care costs, we must reject attempts to strike 
this provision from the bill before us today.
  I believe that a good deal of my colleagues' skepticism is due to a 
fundamental misunderstanding of the FDA's approval process and of the 
provisions of this bill.
  First of all, it is important to point out that this provision 
applies only to punitive damages. Plaintiffs harmed by an FDA-approved 
drug or medical device will still be able to get the full range of 
compensatory damages, including all past and future out-of-pocket 
expenses such as medical bills, rehabilitation costs, lost wages, 
diminished earning capacity, costs of providing household or child care 
services. S. 687 also places no limits on noneconomic damages such as 
pain and suffering or loss of companionship.
  Second, the FDA approval process is extremely rigorous, and involves 
very difficult scientific judgments. The FDA does not take its role in 
approving drugs and devices lightly. In fact, the average length of 
approval for new drugs is 9 years, which, in my judgment, is far too 
long and in itself stifles innovation.
  Moreover, section 203(b) applies only to those manufacturers who have 
complied fully with the FDA requirements after a product is approved. 
And, it does not apply if FDA approval was achieved as a result of 
bribery or if any relevant information required to be submitted was 
withheld from the FDA.
  Finally, Mr. President, I would like to address several misstatements 
of fact that have been made over the last few weeks.
  Some have said that products such as Dalkon shield, DES, and silicone 
gel breast implants, demonstrate that this provision will shield 
manufacturers of dangerous products from legal liability. The fact, 
however, is that none of these products has ever been approved by the 
FDA as safe and effective. Under S. 687, only those products that have 
been approved by FDA qualify for protection.
  Opponents of this measure also argue that it will allow manufacturers 
to get away with putting unsafe products on the market. However, 
manufacturers will continue to have strong incentives to put safe 
products on the market because they will be fully liable for all harm--
and compensatory damages alone can bankrupt a company.


                               conclusion

  Mr. President, it is not often that I find myself in total agreement 
with my colleagues Senator Rockefeller, Senator Dodd, and Senator Pell, 
as well as Senator Gramm, Senator Helms, and Senator Faircloth on any 
one issue. I am grateful particularly to the persistence of Senator 
Rockefeller to pursue this legislation as aggressively as he has. This 
legislation should not be controversial, yet it is perceived to be a 
threat by those lawyers who greatly benefit from successful law suits 
including large punitive damages. Our goal here today should be to 
protect Americans who suffer from use of defective products as well as 
to provide new and better choices for our citizens. This bill meets 
those goals.
  There is broad bipartisan support which exists across the entire 
political perspective on this issue. The legislation is carefully 
balanced and deserves our support.
  At this point, I would like to submit for the Record a description of 
the FDA's reporting requirements for drugs and medical devices.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

  Food and Drug Administration [FDA]--Federal Report Requirements on 
                       Drugs and Medical Devices


                         drugs (21 cfr 314.80)

       Manufacturers are required to keep records relating to 
     production methods for a drug and its safety and 
     effectiveness once a new drug is approved. In general, 
     companies must report to FDA every 3 months during the first 
     year, every 6 months during the second year, and once a year 
     after the first two years.
       All serious and unexpected adverse drug experiences must be 
     reported to FDA within 15 working days under the title of a 
     15-day Alert Report. Adverse drug experiences that are not 
     both serious and unexpected need only be reported at 
     quarterly intervals for the first three years, and then 
     annually.
       The company shall maintain, for a period of ten years, 
     records of all adverse drug experiences including raw data 
     and any correspondence relating to adverse experiences.
       All adverse reaction reports are available under Freedom of 
     Information Act (FOIA) requests.


                      medical devices (21 cfr 803)

       FDA requires device manufacturers or importers to report to 
     FDA whenever the manufacturer or importer receives or 
     otherwise becomes aware of any information that reasonably 
     suggests that one of its marketed devices:
       (1) may have caused or contributed to a death or serious 
     injury; or
       (2) have malfunctioned and that the device or any other 
     device marketed by the manufacturer or importer would be 
     likely to cause or contribute to a death or serious injury if 
     the malfunction were to occur.

          Report requirements by manufacturers (21 CFR 803.24)

       Manufacturers and importers must submit such reports to the 
     FDA whenever they receive or otherwise become aware of any 
     information: oral or written; in a medical or scientific 
     literature, published or unpublished; or through a 
     manufacturer's own research, testing evaluation, serving or 
     maintenance of one of its devices.
       Such reports must be made by telephone as soon as possible, 
     but no later than within 5 calendar days of the initial 
     receipt of information, and followed by a written report to 
     FDA within 15 working days of the initial receipt of 
     information.

             Public availability of reports (21 CFR 803.9)

       Any report, including any FDA record of a telephone report, 
     submitted under the provisions is available for public 
     disclosure.

               Recordkeeping requirements (21 CFR 803.31)

       Manufacturers are required to keep records for the life of 
     the device or two years, whichever is greater.


                           Order of Procedure

  Mr. MITCHELL. Mr. President, following the vote on cloture, I 
convened a meeting in my office of several Senators who are involved 
directly in this matter, both proponents and opponents of the 
legislation, and we discussed the best way in which to proceed. 
Following that discussion I made a decision which I will now announce 
and which I believe all of the Senators involved concur in.
  Following my remarks, Senator Gorton will be recognized to withdraw 
his amendment.
  Following that, Senator Dorgan will be recognized to offer an 
amendment. That will be the pending amendment. And there will be no 
vote on that amendment prior to the cloture vote, which will occur at 
10 a.m. tomorrow. So, therefore, I can now announce there will be no 
further rollcall votes this evening. Both staffs may notify Senators of 
that fact. The next vote will be the cloture vote at 10 o'clock 
tomorrow morning and then, depending upon the outcome of that vote--how 
we proceed thereafter will be dependent upon the outcome of that vote.
  There will be debate this evening on the Dorgan amendment, after it 
is offered, for so long as Senators wish to address that subject. But 
there will be no recorded votes.
  I would like to now, before we proceed--I am going to ask Senators 
Gorton and Rockefeller, and Senator Heflin, if I may have the attention 
of the Senator from Alabama--I will ask Senators if I have correctly 
stated the understanding which we have just reached with respect to our 
present proceeding?
  Mr. GORTON. You have.
  Mr. HEFLIN. I understand there will be no votes, even on the Dorgan/
Moseley-Braun amendment, before the cloture vote. The next vote will be 
cloture?
  Mr. MITCHELL. That is correct.
  Mr. ROCKEFELLER. Will the majority leader yield? Will this 
arrangement contemplate an hour of discussion prior to the 10 o'clock 
cloture vote?
  Mr. MITCHELL. Under the rules there would ordinarily be a cloture 
vote 1 hour after the Senate convenes. We have now set the cloture 
vote, by unanimous consent, and I inquire of the parties--I will 
inquire of Senator Rockefeller and Senator Heflin, and Senator 
Hollings, whether they wish to have that further debate tomorrow 
morning or whatever time is convenient for my colleagues?
  Mr. ROCKEFELLER. The Senator would prefer it.
  Mr. HEFLIN. We would have no objection, after morning business.
  Mr. MITCHELL. I ask the staff, in preparing for the close of business 
this evening, that the order be prepared in such a way that the Senate 
will come into session--at least return to this matter at 9 a.m., and 
have a vote at 10 a.m., and that hour will be equally divided in the 
usual form between the two sides, under the control of Senator 
Rockefeller in favor, the proponents, and Senator Heflin will control 
the time in behalf of the opponents. Senator Rockefeller or his 
designee or Senator Heflin or his designee will control the time.
  Mr. LAUTENBERG. Will the majority leader yield?
  Mr. MITCHELL. Yes.
  Mr. LAUTENBERG. I am sorry I missed some part of the discussion. Is 
it the intention to stay in session now and deal with the bill?
  Mr. MITCHELL. For debate only. Senator Gorton is going to withdraw 
his amendment. Senator Dorgan is going to offer an amendment and that 
will be the subject of debate only. The next vote will be on cloture at 
10 a.m. tomorrow.
  Mr. LAUTENBERG. Is it the intent of the managers to permit amendments 
beyond that which have been discussed to be offered this evening?
  Mr. MITCHELL. The opponents have indicated they will not permit a 
vote on the Dorgan amendment. No discussion occurred with other 
possible amendments. That would, of course, require Senator Dorgan's 
amendment be set aside. And that would require unanimous consent, 
including his. There was no discussion of that in our meeting. I expect 
the Senator from New Jersey, if he wants to do that, would have to 
inquire of the Senators involved.
  Mr. LAUTENBERG. I thank the majority leader.
  Mr. MITCHELL. Mr. President, if it is agreeable then--and I take the 
remarks of the Senators to indicate that it is agreeable--I repeat, 
there will be no further rollcall votes this evening. The next rollcall 
vote will be at 10 a.m. tomorrow on cloture on the bill.
  I thank my colleagues for that cooperation and I yield the floor.


                           amendment no. 1941

  Mrs. KASSEBAUM. Mr. President, I was wondering if the distinguished 
Senator from Connecticut might be willing to answer a few questions 
with respect to the impact of S. 687 on suits against manufacturers of 
drugs and medical devices. While many of these points have been 
mentioned in this debate, I would appreciate further clarification.
  First, as I understand it, the statute of limitations provisions of 
S. 687 will ensure that individuals who may be exposed to a harmful 
product will not lose their right to sue before they reasonably could 
have known both that they were injured and that the product may have 
caused their harm. This in essence means that in a number of States, S. 
687 will make it easier, not harder to sue drug and medical device 
companies.
  Mr. LIEBERMAN. The Senator from Kansas is correct. Section 204 
provides a uniform statute of limitations of 2 years from the date a 
claimant knew or should have known both of the injury and its cause. It 
will have exactly the effect you outlined.
  Mrs. KASSEBAUM. There have been many accusations that the so-called 
FDA provisions of this bill would prevent persons who are injured by 
FDA approved drugs and medical devices from seeking compensation from 
manufacturers. As I read section 203(b), however, it applies only to 
claims for punitive damages, not to claims for compensatory damages, so 
that claimants will still be able to sue under State law for any 
compensatory damages, just as they do now.
  Mr. ROCKEFELLER. Again the Senator from Kansas is correct. Section 
203(b) has no impact on claims for compensatory damages such as lost 
wages, medical costs, costs of replacement services or pain and 
suffering.
  Mrs. KASSEBAUM. I know the Senator has said this before, but it is my 
understanding from reviewing this legislation that the so-called FDA 
provision does not cover DES, Dalkon Shields, silicone gel breast 
implants, or super-absorbency tampons. Am I correct?
  Mr. LIEBERMAN. The Senator is correct. Section 203(b) only provides 
``good actor'' protection against punitive damages if the product is 
subject to pre-market approval by the FDA and is actually approved. 
Pre-market approval is a very specific concept under our food and drug 
laws. As the Senator, the ranking member of the Committee on Labor and 
Human Resources, knows, when DES was first marketed and prior to 1962, 
new drugs could be placed on the market without any formal action by 
FDA. At that time, all a company had to do was file information with 
FDA indicating that a product was safe, and if FDA did not respond 
within 60 days, the manufacturer could go ahead and market it. This 
type of system is pre-market notification, not pre-market approval. A 
drug could also be placed on the market at that time if it was 
``generally recognized as safe.''
  In 1962, Congress changed the drug laws completely. After 1962, new 
drugs could not be placed on the market until FDA actually approved the 
new drug application, unless the drug was found to be ``generally 
recognized as safe and effective.'' These are the two tests we use in 
section 203(b) with respect to drugs: was the drug actually approved 
under a new drug application, or was it generally recognized as safe 
and effective. DES was never generally recognized as safe and 
effective, and it was never actually approved under a post-1962 drug 
application. Thus, DES is not covered under section 203(b).
  A similar analysis applies with respect to Dalkon Shields and breast 
implants. Both of those products were placed on the market prior to 
enactment of the Medical Devices Amendments of 1976. Dalkon Shields 
were marketed entirely prior to 1976, so they could never have received 
FDA approval. Silicone gel breast implants were grandfathered because 
they were already on the market in 1976. Grandfathered devices did not 
need to receive pre-market approval. Thus, neither Dalkon Shields nor 
silicone gel breast implants are covered by the FDA/punitive damages 
provisions.
  Super absorbency tampons are class II medical devices, and hence are 
not subject to pre-market approval by FDA. Thus, they are not covered 
by section 203(b) either.
  Mrs. KASSEBAUM. I notice that a number of the ``horror stories'' 
cited by opponents of S. 687 are cases in which claimants regularly 
assert that the manufacturer failed to submit required information to 
the FDA. One such case involved a copper-7 IUD. In another recently 
publicized case, a manufacturer of cardiac catheters, C.R. Bard, was 
found to have engaged in criminal withholding of information from the 
FDA. As I read S. 687, it provides no punitive damages protection for 
manufacturers who have failed to abide by their FDA duties and who have 
been sued because of a resulting injury.
  Mr. LIEBERMAN. The Senator is again correct. In every ``horror 
story'' of which I am aware, claimants have alleged that the 
manufacturer did not supply required information to the FDA.
  Mrs. KASSEBAUM. I have one other question. Opponents of this 
legislation have been claiming that the provision making liability for 
noneconomic losses several rather than joint hurts women because they 
cannot recover fully for reproductive injuries in drug and medical 
device cases. From what I am told, however, joint liability is rarely 
an issue in drug and medical device cases. Before joint liability can 
be an issue, there must be two people who helped cause the harm. In 
drug and device cases, however, the only party that caused the harm is 
the manufacturer. Thus, joint liability cannot be an issue in those 
cases.
  Mr. LIEBERMAN. Again the Senator is correct. Joint liability is 
simply not an issue in most drug and medical device cases. 
Interestingly enough, in DES and other market share liability cases, in 
which there are often several defendants, courts have refused to make 
liability joint. Courts have viewed joint liability as inconsistent 
with market share liability.
  Mrs. KASSEBAUM. Based on what I know about the provisions of S. 687 
governing punitive damages for FDA approved products and several 
liability for noneconomic harm, I simply do not believe that S. 687 is 
antiwoman. In fact, passage of S. 687 could substantially help women. 
The Institute of Medicine has recommended enactment of an FDA 
compliance defense as a means of lowering one of the significant 
barriers to the development of new contraceptives. By encouraging 
research, development and innovation in the health field, S. 687 could 
help to spur the development of products to diagnose and treat 
osteoporosis, breast cancer, and cervical cancer.
  I believe the provisions of S. 687 granting ``good actor'' protection 
against punitive damages to manufacturers who comply fully with FDA 
requirements will have an extremely positive effect on the public 
health. I urge my colleagues not to strike section 203(b), and to vote 
to support cloture on this bill.
  The PRESIDING OFFICER. The Senator from Washington is recognized.
  Mr. GORTON. Mr. President, I withdraw the first-degree amendment.
  The PRESIDING OFFICER. The Senator has that right. The amendment is 
withdrawn.
  So the amendment (No. 1941) was withdrawn.
  Mr. DORGAN addressed the Chair.
  The PRESIDING OFFICER. The Senator from North Dakota.


                           Amendment No. 1895

(Purpose: To eliminate provisions limiting punitive damages concerning 
 certain drugs and medical devices and certain aircraft and components)

  Mr. DORGAN. Mr. President, I send an amendment to the desk. It is 
amendment No. 1895. The amendment is offered on behalf of myself, 
Senator Moseley-Braun, Senator Mikulski, Senator Riegle, and Senator 
Feinstein.
  The PRESIDING OFFICER. The clerk will report amendment No. 1895.
  The legislative clerk read as follows:

       The Senator from North Dakota [Mr. Dorgan], for himself, 
     Ms. Moseley-Braun, Ms. Mikulski, Mr. Riegle, and Mrs. 
     Feinstein, proposes an amendment numbered 1895.

  The amendment is as follows:

       On page 19, beginning with line 7, strike out all through 
     line 6 on page 22.

   Mr. DORGAN. Mr. President, I will be brief, and then I would like to 
call on my colleague, Senator Moseley-Braun, who has worked with me in 
recent weeks in preparing this amendment. This is a very short 
amendment and a very simple amendment. It is substantial in its 
consequences but, nonetheless, simple.
  It simply strips from this bill that the Senate is now considering 
the provision, section 203, that establishes a test for manufacturers 
with respect to punitive damage awards and FDA and PAA approval. And 
that test is that if the FDA or FAA has approved their products, then 
there is developed a shield behind which it is much more difficult to 
seek punitive damages from the manufacturer. In other words, it 
establishes a protection for manufacturers if the Federal agency, in 
this case the FDA or FAA, has approved the product.
  I have said before--I will be very brief now because I spoke 
earlier--I said it is legion to review the products that have been 
approved in good faith by the FDA that later proved to be very 
troublesome products: The Dalkon shield, DES, silicon breast implants, 
and a range of areas. I have gone through a list of drugs and medical 
devices. I will not repeat them.
  But it is clear that the FDA has not been capable, nor should we 
expect it to be capable, of approving a range of drugs and a range of 
medical devices, to say that we have the staff, we have the capability, 
we have the investigative power--of saying when we approve this, we 
understand it does no harm and we represent that to be the case and we 
will construct from that a shield to protect manufacturers against 
punitive damages.
  The Senator from Illinois, Senator Moseley-Braun, and I feel strongly 
that this is a terrible provision in this bill and it must be 
eliminated.
  If we eliminate this provision in this bill, I said on the floor 
previously and I will say again that I will support this piece of 
legislation. But this provision in this bill is very troublesome and, 
in my judgment, should not advance.
  Mr. GORTON. Will the Senator from North Dakota yield for just a 
moment?
  Mr. DORGAN. I will be happy to yield to the Senator from Washington.
  Mr. GORTON. Mr. President, as the Senator from North Dakota well 
knows, this Senator, as one of the primary sponsors of the bill, 
disagrees with his friend's characterization of the FDA defense against 
punitive damages under certain circumstances and has spoken vehemently 
over an extended period of time in favor of just that provision.
  As this Senator has assured his friend from North Dakota privately, 
in order to get a bill through with which the Senator from North Dakota 
and the Senator from Washington agree, leaving this portion of it 
aside, this Senator is, in fact, going to vote in favor of the 
amendment proposed by the Senators from North Dakota and Illinois and 
will undertake to persuade as many of his colleagues on this side of 
the aisle to follow his lead as is possible; that he feels a very large 
number of them, or a very substantial number of them will do so.
  The Senator from Washington makes that assurance because it is quite 
evident now that opponents to the bill will prevent the amendment 
proposed by the Senator from North Dakota from coming for a vote before 
tomorrow's cloture vote. But I simply want the two Senators who are 
sponsoring this amendment to know that whatever my view on the merits, 
I will vote with them and I will undertake to secure a sufficient 
number of votes from this side to assure, as much as can ever be 
assured, that they will, in fact, be victorious.
  Mr. DORGAN. Mr. President, I appreciate the Senator's comments. It 
has been some months since we marked this bill up in the Commerce 
Committee and moved it forward. During those months, Senator Moseley-
Braun and I have worked on this issue because we have felt very 
concerned about this.
  This is a sea change of sorts, when he says he will support this 
amendment. Our dilemma at the moment, of course, is we are told we may 
not get a vote on this amendment prior to the next cloture vote, and we 
will have to talk some about that. I hope that is not the case, but 
some suggest they do not want to vote on this and will continue talking 
about it.
  Having gone through this a few minutes ago, let me at this point 
suspend; and my colleague from Illinois, Senator Moseley-Braun, I 
think, can state this better than can I. Let me yield the floor, Mr. 
President, so that my colleague, who has worked very hard on this over 
the last months, may speak to it.
  Mr. President, I yield the floor.
  The PRESIDING OFFICER. The Senator from Illinois.
  Ms. MOSELEY-BRAUN. Mr. President, there is an old expression that 
says that those who love the law or sausages should not watch either of 
them being made. I daresay that is the situation with which we are 
confronted with regard to the pending amendment and with regard to 
produce liability reform in general.
  Let me say at the outset, Mr. President, that I have voted against 
cloture primarily because I was concerned about problems with this 
legislation and convinced that the problems in this legislation, 
particularly the problems related to the FDA and FAA excuse, did not 
overcome the merits of the legislation.
  The merits of the legislation include the fact that I believe we 
really do need to have some national standards in the area of product 
liability. Without rational standards, people are sent pillar to post 
to defend actions with different standards and different rules. I do 
believe that there has been abuse with the operation of our tort law in 
this country.
  That argument has been raised by manufacturers who say that shipping 
their products is made more expensive by operation of the tort laws in 
our country. And there has been a great deal of discussion about the 
larger impact that product liability laws have on the competitiveness 
and stability of businesses in this country.
  What Senator Dorgan and I have specifically tried to address is one 
narrow portion of this bill, in an effort to make the legislation a 
better bill, in an effort to address the specific issues that concern 
the rights of victims, of little people, who may not be heard 
otherwise. While the battle over product liability law is largely a 
battle of the network giants, a battle of big-picture issues and huge 
interests, Senator Dorgan and I have tried to take steps to protect the 
forgotten consumer.
  The pending amendment relates specifically to the health and safety 
of those who may be injured by defective drugs and medical devices that 
are approved by the FDA or by aircraft components approved by the FAA.

  S. 687 provides what we call the FDA excuse. I know the Senator from 
Washington disagrees with my characterization. But essentially what it 
says is that a person cannot get punitive damages for a defective 
medical device, such as an IUD or silicon breast implant; or a 
defective medical drug, so long as that device or drug had received 
premarket approval from the FDA, so long as the FDA said the device was 
OK. That turns tort law, as we have always known it, on its head, and 
establishes an administrative agency as a gatekeeper to decide what 
damages might otherwise be allowed in the law.
  We know from experience that FDA is understaffed, overworked, and 
does not have the capacity to do the kind of analysis, to do the kind 
of research, to actually guarantee that the public will not be 
subjected to unreasonably dangerous drugs or medical devices.
  So this FDA excuse will have the effect of shifting responsibility 
from the manufacturers of the defective products to the Government. 
That struck Senator Dorgan and me as being inappropriate; that this 
shifting of responsibility was not what S. 687 intended to do and that 
it was not what the proponents of this legislation wanted to do; and 
that it was entirely inappropriate, in fact, to place with an 
administrative agency in this level of control over the rights of 
victims of defective medical devices and products.
  Happily, I think, the managers of this legislation have agreed with 
Senator Dorgan and me with regard to the FDA excuse. They have agreed 
that our amendment, which simply strikes those portions of the bill 
relating to the FDA and FAA excuse, should be adopted.
  So the whole section of the bill relating to what we call the FDA 
excuse would be stricken, taken out of the bill, by virtue of this 
amendment.
  I would like to add, having worked on the amendment for a number of 
months now, Senator Dorgan and I have now been joined by three 
additional cosponsors--Senators Reigle, Mikulski, and Feinstein--
because it really is a good idea. It is a good idea for protecting 
people, and by that I mean the ordinary people, not the big money 
interests, not the big giants, but the folks who actually might suffer 
an injury from an FDA or FAA approved product.
  Well, that may sound straightforward, Madam President, but the 
problem is that our amendment addresses the merits and not the 
procedure. And so here we are in a situation in which we have achieved 
consensus on both sides of the aisle that striking the FDA and FAA 
excuse provisions of the bill is the right thing to do. The managers of 
the bill say it is the right thing to do; Senator Dorgan and I, our 
three cosponsors say it is the right thing to do; everybody believes 
this is a meritorious proposal, one that really will take a positive 
step to make this bill a better bill. We have consensus on that. But we 
are now stymied by the procedure relating to this legislation.
  Now, there are those who say that this legislation has been around 
for 14 years now, a long time before I got here or Senator Dorgan got 
here or I daresay any number of Senators arrived in this body. This 
legislation has very long teeth, indeed, not to mention legs.
  But the fact is this is the first time we have been able to raise 
this issue of the FDA and FAA excuse, and I think Senator Dorgan and I 
have raised it responsibly. I think we have raised it in a way that was 
not calculated to make controversy but, rather, to reach consensus. And 
were, in fact, able to reach consensus. However, unfortunately, it does 
not now appear that we will be able to have a vote on this amendment 
before there is a vote on cloture on the underlying bill as a whole. So 
this meritorious proposal is being held hostage to the larger questions 
relating to this legislation. That is unfortunate, but that is the 
legislative process. That is the way things go in the legislative 
process. I hope to have the support of my colleagues to vote in support 
of the amendment that has been offered by Senator Dorgan and I if we 
do, in fact, get a chance to vote on it. If we do get a chance to vote 
for it, I hope we are able to make this bill a better bill and a bill 
of which this Senate can approve.
  I yield.
  Mr. DORGAN addressed the Chair.
  The PRESIDING OFFICER (Mrs. Murray). The Senator from North Dakota.
  Mr. DORGAN. Madam President, I ask for the yeas and nays on this 
amendment.
  The PRESIDING OFFICER. Is there a sufficient second? There appears to 
be a sufficient second.
  The yeas and nays were ordered.
  Mr. DORGAN. I yield the floor.
  Mr. ROCKEFELLER. Will the Senator yield?
  Mr. DORGAN. I would be pleased to yield.
  The PRESIDING OFFICER. The Senator from West Virginia.
  Mr. ROCKEFELLER. Madam President, first of all, I wish to say I know 
that the Senator from North Dakota wants to get home, because he has 
family obligations, and I do not think we are going to do much more 
tonight unless the Senator himself wishes further discussion. I will be 
available for so long as people want.
  But I would like to repeat what Senator Gorton said, that the FDA/FAA 
amendment had a lot of merit. On the other hand, we have not been able 
to discuss this bill for 13 years because it has been filibustered by 
the same people who are apparently going to filibuster it through 
tomorrow and cloture.
  Now, if we get cloture, then we will have a vote, and I think if we 
have a vote, we will prevail. And we will prevail with a bill, as the 
Senator from Illinois has said, that is a much improved bill.
  I very strongly, proudly and happily join with the Senator from North 
Dakota and the Senator from Illinois in deleting this provision because 
I think for the overall public purposes of what we are doing, it does 
make it a stronger bill. I would therefore encourage my colleagues, as 
they think tonight and tomorrow, that although in the legislative 
process filibustering is a useful technique, particularly as used in 
the civil rights era, and it has been used from time to time since 
then. But this is really a full-fledged filibuster that we are talking 
about now. And I think that those who oppose this will simply not stop 
talking unless we can get cloture tomorrow. If we can get cloture 
tomorrow, I think we can pass a bill which will not have the FDA/FAA 
part. And then I will myself say to the Senator from North Dakota and 
the Senator from Illinois that it is true the FDA is not perfect, and 
it is true that they may not have enough people, and these are things 
that now we do not have to worry about because that is no longer a part 
of the bill.
  So I would urge my colleagues to prayerfully consider their cloture 
vote tomorrow, that I hope they would vote for cloture because we now 
have a substantially different bill and I think a substantially better 
bill. I hope they would consider that, and that when they come to vote 
tomorrow they will understand this is a major adjustment in the bill 
and that cloture will prevail.
  I thank particularly my colleague from North Dakota and also from 
Illinois because they have been professional, calm, reasonable, and 
just good in the way they have handled this whole situation. I wish to 
thank them.
  With that, I would yield the floor.
  Mr. DORGAN. Madam President, as I understand it, there is an hour of 
debate tomorrow morning before the cloture vote, and I think it would 
be useful to come back to the subject and continue in some additional 
detail on section 203. I know the Senator from Illinois would like to 
do that, and I would as well.
  I appreciate the comments of the Senator from West Virginia. As he 
knows, this is not a new discussion. This discussion occurred the same 
day this amendment passed the Senate Commerce Committee, and we are now 
some months later at the very point of contention: what about this 
section?
  I appreciate the likelihood at this point that we may get beyond this 
and strip this away. We do have a situation where a cloture vote is 
scheduled for 10, and it appears we will not be able to deal with this 
amendment before the cloture vote, so we are going to have to discuss 
that. But in any event I think we have made some progress for those of 
us who believe that this amendment must leave this piece of 
legislation, and if it does that we would support advancing the 
legislation.
  Madam President, I yield the floor.
  Mr. HOLLINGS addressed the Chair.
  The PRESIDING OFFICER. The Senator from South Carolina.
  Mr. HOLLINGS. Let us make the record clear. The distinguished Senator 
from Illinois used the proper word this morning, ``masquerade.'' The 
masquerade continues.
  I intend to vote for the amendment to strike because any time I can 
get any section of this bill out; it is that bad, it is that much a 
travesty, I am going to support getting it out. But the masquerade does 
continue when you come in and say you want uniformity but then put a 
sentence that this shall not constitute a Federal cause of action, 
sending you to the 50 several jurisdictions--all these words of art 
when you talk about in the proof of punitive damage the conscious, 
flagrant disregard of safety, and it has to be proved by clear and 
convincing. When you say to a seriously injured female under these drug 
cases you do not have any economic loss--yes, you can get a small 
verdict for the economic loss, but for the pain and suffering and the 
noneconomic, we have to get to the proof of several liability on each 
one of the several parties--you have given me quite a task of 
interrogatories, various discoveries and so on.
  Then when you come to settlement, the so-called settlement is a 
misnomer if there ever was one because there is an offer made and under 
rule 68 a continuing offer made. So the corporate counsel sits up there 
and he measures just where he is continually bringing pressure with the 
employer of the injured person.
  You see, there can be no settlement unless the employer is notified 
and joins in. Of course, the insurance company for the manufacturer 
gets in touch with that employer, and, says, ``Here is what we will 
offer. There is enough money here to take care of your workmen's 
compensation, and what you paid for salaries while the injured party 
was home sick,'' and otherwise, and, says, ``We can take care of that, 
and you had better tell the injured party the sentence so we can get 
your money.''
  So you bring not only the corporate counsel against you. You bring, 
by gosh, the employer against you. Then if you happen to get a little 
bit, $1 more, you are in trouble because the $1 more cancels out the 
contingency contract. There is a cap on so-called attorney's fees. That 
has already been eaten up in the contract itself. The contract itself 
was discontinued. But on the other hand, if you get less, I can tell 
you here and now what happens. All your collateral benefits are 
assessed against your particular verdict, and if you had a health 
insurance policy that is taking care of your hospitalization and 
medical costs, that is fine business. But that is not what you paid for 
to be injured. You are the winner. You have won in the one case and you 
proved to all 12 jurors the burden has been on you, and it has been a 
clear and convincing burden.
  You come around, and even a several burden, and you have done all of 
these things after 2 years. Then they take away, let us say $100,000, 
and the insurance costs that you put out there. Otherwise, if you had 
life insurance, and there is a loss of life involved in the case, I can 
tell you exactly what happens. All of that has gone. Of course you have 
been paying premiums for 30 or 40 years, like all of us have, to 
protect yourself with life insurance, not to become a winner in a 
lawsuit and a damage suit. But the winner then becomes the loser. 
Because you won, they cancel out all of your insurance benefits. You 
have to assess that against your verdict.
  So it is nice to be so condescending and tell everybody how wise you 
are--and each Senator has his or her own needs.
  But I can tell you here and now that will get rid of this 
abomination. This bill is calculatedly bad. If they have you down the 
side road of the FDA, and still getting this bad bill passed, then we 
have not done our job for the injured parties in America here tonight, 
or tomorrow morning.
  So I want everybody to get to look at the bill in its entirety. It 
has been very difficult to discuss the entire measure. I refute the 
idea of filibustering. You cannot come in and say we filibuster and 
discussed the case but we never discussed the case. I mean, come on. 
Which way do you want it? The fact of the matter is we have discussed, 
discussed, and discussed again this particular bill in different forms. 
It still is what the Chief Justices' Association, every consumer 
organization, the attorneys general, legislatures, American Bar 
Association, every woman's health group has come out against this 
measure.
  That is why it has not passed in these years. It has not been the 
trial lawyers, and it has not been filibustered. It has been a very, 
very bad bill. The States are not coming to Washington and saying 
federalize this thing and give us half a haircut with a part 
federalized and a part not federalized. They have said leave us alone.
  Here is a great moment for those who always wanted to, by gosh, defer 
to the States' responsibilities. There is no crisis in litigation 
costs, availability of insurance, and otherwise. They come now with 
this gimmick. It has been a gimmick. It continues to be one. It is a 
bad gimmick. It is a travesty on the injured parties in America.
  I hope we can still vote cloture and continue to work against this 
bill.
  I yield the floor.
  Mr. ROCKEFELLER addressed the Chair.
  The PRESIDING OFFICER. The Senator from West Virginia.

                          ____________________